27th May 2025 08:36
(Alliance News) - AstraZeneca PLC on Tuesday said its Imfinzi, or durvalumab, therapy has been recommended for approval in the EU for the treatment of muscle-invasive bladder cancer.
The Cambridge-based pharmaceutical and biotechnology company said the European Medicines Agency's Committee for Medicinal Products for Human Use recommended the approval of the drug in combination with gemcitabine and cisplatin as neoadjuvant treatment, followed by its use as monotherapy adjuvant treatment after radical cystectomy, a surgery to remove the bladder.
The committee based its positive opinion on results from the Niagara phase 3 trial, in which the Imfinzi-based perioperative regimen demonstrated a 32% reduction in the risk of disease progression or recurrence compared to the current standard of care.
"The Imfinzi-based perioperative regimen in the Niagara phase 3 trial enabled survival of more than 80 per cent of patients at two years after treatment. This supports our strategy of moving our innovative medicines into the earlier stages of disease where the opportunity for treatment with curative intent is greatest," said Executive Vice President Susan Galbraith.
"If approved, this novel approach will become a much-needed new treatment option for patients in Europe and could become the new standard of care in this setting," Galbraith added.
Imfinzi is currently approved in the US and other countries based on the Niagara results. Regulatory applications are currently under review in Japan and elsewhere.
Shares in AstraZeneca were up 0.8% to 10,516.00 pence in London on Tuesday morning.
By Michael Hennessey, Alliance News reporter
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